Clinical Research Program/Project Manager-Saxena Lab

Apply online here: https://partners.taleo.net/careersection/ghc/jobdetail.ftl?job=3111851

The Saxena Laboratory in the Center for Genomic Medicine at Massachusetts General Hospital (MGH) is seeking a motivated, enthusiastic candidate to join our research group. Our research group uses human genetics and complementary strategies to: (1) identify the genetic basis of sleep and circadian rhythms; (2) reveal mechanistic links between sleep/circadian rhythms and and type 2 diabetes and other chronic diseases; (3) ascertain fetal and maternal genetic risk factors performed. 50% of the candidate’s time will be spent working directly with Saxena lab projects.

Additionally, the Clinical Research Program/Project Manager will manage and provide bioinformatics and study coordination support for research projects within the MFM division (located at the BWH). Many of the duties will be related to the ongoing longitudinal pregnancy cohort, LIFECODES, a biobank of samples and data from more than 3000 pregnancies collected since 2009.  50% of the candidate’s time will be spent working directly with BWH MFM division projects.

PRINCIPAL DUTIES AND RESPONSIBILITIES: 

* Writes operations manuals

* Prepares Case Report Forms

* Edits manuscripts

* Supervises operations of all study staff

* Resource for patients and staff

* Monitors drug accountability logs

* Coordinates multi-center trials with NIH, FDA and private foundations

* Oversees all study meeting plans

* Reports study progress at investigators’ meetings

* Takes minutes at central meetings/conference calls and disburses information to investigators/sponsor

* Attends conferences

* Collects and organizes patient data

* Maintains records and databases

* Uses software programs to generate graphs and reports

* Assists with recruiting patients for clinical trials

* Obtains patient study data from medical records, physicians, etc.

* Conducts library searches

* Performs administrative support duties as required

* Verifies accuracy of study forms

* Updates study forms per protocol

* Prepares data for analysis and data entry

* Assists with formal audits of data

* Documents patient visits and procedures

* Assists with regulatory binders and QA/QC procedures.

* Assists with interviewing study subjects

* Administers and scores questionnaires

* Provides basic explanation of study and in some cases obtains informed consent from subjects

* Performs study procedures such as phlebotomy,

* Assists with study regulatory submissions

* Writes consent forms

* Verifies subject inclusion/exclusion criteria

* Maintains research data, patient files, regulatory binders and study databases

* Performs data analysis and QA/QC data checks

* Organizes and interprets data

* Develops and implements recruitment strategies

* Acts as study resource for patient and family

* Monitors and evaluates lab and procedure data

* Administers/scores/evaluates study questionnaires

* May contribute to protocol recommendations

* Assists with preparation for annual review

* May assist PI to prepare complete study reports

* Responsible for quality control

* Reviews work of trainees

* Develops study budgets

* Coordinates lab activities

* Plans, performs and designs statistical analyses

* Designs research protocols in conjunction with PI

* May develop systems for QA/QC

* Independently judges suitability of research subjects

* Acts as liaison between Research Affairs and Unit

* Files adverse events with IRB

* Recommends protocol changes and may assist

with writing protocols and manuscripts

* Acts as a liaison with Human Resources

* May assume grant management responsibilities for

unit.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:  

* Ability to make independent effective decisions

* Strong organizational and communication skills

* Ability to effectively supervise and train staff.

* Strong database management and overall computer skills

* Demonstrated analytical skills to problem solve effectively

* Must possess strong budget management skills

EDUCATION: 

BS/BA Required

MA/MS/MPH Preferred

EXPERIENCE:

Minimum of 5 years of research experience required, preferably in obstetrics and gynecology. Prior Supervisory experience strongly preferred.

SUPERVISORY RESPONSIBILITY (if applicable):  

May have direct responsibility for management for project staff

WORKING CONDITIONS:

Laboratory/Office Setting

Apply online here: https://partners.taleo.net/careersection/ghc/jobdetail.ftl?job=3111851